MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problems Headache (1880); Hypoglycemia (1912); Malaise (2359)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.Patient stated that before she went into her appointment her cgm said she was at 55mg/dl and when she tested she was at 92mg/dl.Patient stated that it was happening often so she would treat according to the dexcom and then it would be way off 30 minutes later.Patient stated that her numbers were shooting up super high and then shooting down super fast to the point where she was feeling miserable: horrible headaches, major forgetfulness, etc.Patient's blood sugars even dropped below 40mg/dl and her dexcom cgm still read above 80mg/dl.Patient felt like her body recognized her symptoms before her dexcom did.No additional event or patient information was provided.No product or data was returned for evaluation.The reported event could not be confirmed.A root cause could not be determined.Treatment decisions were made based on cgm values.The dexcom g5 mobile continuous glucose monitoring system states: the dexcom g5 mobile cgm system does not replace your bg meter.When making treatment decisions, such as the amount of insulin you need, only use your bg value.Don't use the dexcom g5 mobile cgm system sensor glucose readings because readings can be different from your bg value.If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5806662
• MDR Text Key: 49944580
• Report Number: 3004753838-2016-13314
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2016
• Initial Date FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 63